FDA-Device2025-06-04Class II
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Maquet Cardiopulmonary Ag
Hazard
HKH 8820 Wall Holder does not comply with standard DIN EN 1789:20 and has the potential to detach.
Sold states
Domestic: IL & MO. Foreign: Australia, Austria, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, South Korea, Poland, Russia, Saudi Arabia, Spain, Switzerland, Thailand.
Affected count
US: 2 units; OUS: 168 units
Manufactured in
Kehler Str. 31, N/A, Rastatt, N/A, Germany
Products
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1823-2025Don't want to check this manually?
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